Efficacy of a Probiotic Blend to Reduce Gastrointestinal Symptoms in Patients With Irritable Bowel Syndrome

NCT05819281 | Unknown Phase 2 DMC

• 1 other identifier: 63067022.2.0000.0119
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable bowel syndrome (IBS) is a recurrent, functional disorder characterized by abdominal pain and discomfort, changes in bowel habits and gastrointestinal symptoms such as distension and sensation of abdominal inflammation, incomplete evacuation, urgency and tenesmus. In addition to gastrointestinal symptoms, patients with IBS often experience a wide range of other problems, such as non-abdominal pain, psychological symptoms, poor quality of life, and difficulties in carrying out activities of daily living. Studies carried out with probiotics have shown that their administration can be effective in the prevention and treatment of IBS. Our objective is to develop a probiotic product (Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium bifidum e Lactobacillus rhamnosus) is safe and effective in reducing symptoms caused by IBS, as well as improving quality of life. In the present study, 114 volunteers of both genders will be included, randomly distributed into two groups: Test group (n=57): Volunteers supplemented with the probiotic product (Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium bifidum e Lactobacillus rhamnosus- Final concentration: 1 x 1010 CFU/day). Placebo Group (n=57): Volunteers supplemented with placebo. The study will last 90 days and will have 3 visits to apply the proposed questionnaires.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Bristol scale

  The Bristol Stool Form Scale is used for describing feces into seven categories. Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicating lack of dietary fiber, and 6 and 7 indicate diarrhoea. People with irritable bowel syndrome (IBS) typically report that they suffer with abdominal cramps and constipation. In some patients, chronic constipation is interspersed with brief episodes of diarrhoea; while a minority of patients with IBS have only diarrhoea.

  Three times (0, 45 and 90 days after inclusion)

Secondary Outcomes (4)

• Change of quality of life (SF-36 scale)

  Three times (0, 45 and 90 days after inclusion)

• Change of mental health - depression

  Three times (0, 45 and 90 days after inclusion)

• Gastrointestinal Symptom Rating Scale (GSRS)

  Three times (0, 45 and 90 days after inclusion)

• Change of mental health - anxiety

  Three times (0, 45 and 90 days after inclusion)

Study Arms (2)

Probiotic blend group

EXPERIMENTAL

Volunteers supplemented with the probiotic product (n=57) (Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium bifidum e Lactobacillus rhamnosus - Final concentration: 1 x 10e10 CFU/day).

Dietary Supplement: Probiotic blend

Placebo group

PLACEBO COMPARATOR

Placebo Group (n=57): Volunteers supplemented with placebo (maltodextrin)

Dietary Supplement: PLACEBO

Interventions

Probiotic blend DIETARY_SUPPLEMENT

(Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium bifidum e Lactobacillus rhamnosus - Final concentration: 1 x 1010 CFU/day).

Probiotic blend group

PLACEBO DIETARY_SUPPLEMENT

Maltodextrin

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of Free and Informed Consent in writing, signed and dated;
• Age according to the indicated population;
• Patients diagnosed with IBS by a specialist.

You may not qualify if:

• Individuals with a history of daily consumption of probiotics, fermented milk and / or yogurt; subjects known to have demonstrated a prior reaction, including anaphylaxis, to any substance in the composition of the study product;
• Individuals who have unbalanced blood pressure; hx of heart disease, including valvulopathies or any implantable device; individuals on immunosuppressive therapy or any health condition causing immunosuppression; individuals with active, uncontrolled bowel disease such as Crohn's disease or ulcerative colitis;
• Women who are pregnant at the time of enrollment or who plan to become pregnant during the study;
• Individuals with concomitant participation in another clinical trial;
• History of autoimmune disease.

Sponsors & Collaborators

• Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude: lead

Study Sites (1)

Universidade Do Extremo Sul Catarinense

Criciúma, Santa Catarina, 88806000, Brazil

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: April 19, 2023
• Study Start: March 15, 2023
• Primary Completion: March 15, 2023
• Study Completion: December 10, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

BR (1)